Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia

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CSL Behring

Status and phase

Completed
Phase 2

Conditions

Cachexia
Fatigue
NSCLC

Treatments

Biological: ALD518
Biological: Infusion of 0.9% Saline without ALD518

Study type

Interventional

Funder types

Industry

Identifiers

NCT00866970
ALD518-CLIN-004

Details and patient eligibility

About

The purpose of this study is to asses the safety and efficacy of ALD518 in patients with Non-Small Cell Lung Cancer-Related Fatigue and cachexia (weight-loss).

Full description

This is a phase II, double-blind, randomized, placebo-controlled study of ALD518 in patients with NSCLC related fatigue and cachexia. It is estimated that a total of 120 patients will be randomized to ALD518 80 mg, 160 mg, 320 mg, or placebo in a 1:1:1:1 ratio. A total of eight visits (excluding the Screening visit) will take place over a period of 24 weeks: Day 1, Weeks 2, 4, 8, 12, 16, 20, and 24. Enrolled patients will be screened within a 4 week period (Day 35 to 7). Randomization to treatment will be within a 12 day period (Day 14 to 3), before initial dosing on Day 1. Patients will receive treatment eight weeks apart (on Day 1, and Weeks 8 and 16). All patients will remain at the clinic for at least 4 hours from the time the infusion is started. Follow-up visits will occur four and eight weeks after the last dose of study drug, at Weeks 20 and 24, respectively.

Enrollment

124 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Confirmed diagnosis of NSCLC incurable by other treatments including surgery
  • A ≥5 % loss of body weight in the preceding 3 months
  • A C-reactive protein (CRP) concentration ≥ 10 mg/L
  • Life Expectancy of at least 12 weeks

Exclusion criteria

  • Treatment with chemotherapy, large-field radiotherapy, or surgery for treatment of cancer in the past 30 days
  • AST/ALT ≥ 3 x ULN at screening
  • Hemoglobin < 8 g/dL at Screening
  • History of or active diagnosis of Tuberculosis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

124 participants in 4 patient groups, including a placebo group

1
Experimental group
Description:
ALD518
Treatment:
Biological: ALD518
2
Experimental group
Description:
ALD518
Treatment:
Biological: ALD518
3
Experimental group
Description:
ALD518
Treatment:
Biological: ALD518
4
Placebo Comparator group
Description:
No ALD518
Treatment:
Biological: Infusion of 0.9% Saline without ALD518

Trial contacts and locations

43

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Data sourced from clinicaltrials.gov

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